Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma

ISRCTN	ISRCTN23628366
DOI	https://doi.org/10.1186/ISRCTN23628366
ClinicalTrials.gov (NCT)	NCT00005867
Protocol serial number	GOOD RISK
Sponsor	British National Lymphoma Investigation (BNLI) (UK)
Funder	British National Lymphoma Investigation (BNLI) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma
Study acronym	Not Applicable
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lymphoma (non-Hodgkin's)
Intervention	1. CHOP regimen: Chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisolone repeated every 21 days for 6-8 cycles 2. PmitCEBO regimen: Chemotherapy with mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone. Repeated every 14 days for 4-8 cycles
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Various
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Senior
Lower age limit	18 Years
Upper age limit	59 Years
Sex	All
Key inclusion criteria	1. Previously untreated non-Hodgkin's Lymphoma of the following types: follicular large cell lymphoma, diffuse mixed cell lymphoma diffuse large cell lymphoma diffuse immunoblastic lymphoma 0r Revised European/American Lymphoma (REAL) classification: diffuse large B peripheral T cell lymphoma 2. Bulky stage IA and stages IB-IV (Ann Arbour staging system) 3. Age 18-59 years 4. Measurable or evaluable disease 5. Good prognosis, defined as the presence of no more than one of the following adverse features: Stage III/IV Lactic dehydrogenase (LDH) >upper limit of normal Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) Adequate bone marrow function, indicated by Haemoglobin ≥10 g/dL Neutrophils ≥2 x 10^9/L Platelets ≥100 x 10^9/L 6. Written informed consent
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	10/12/1998
Date of final enrolment	31/12/2004

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/05/2009		Yes	No

27/09/2019: ClinicalTrials.gov number added.